San Jose, Calif., Dec. 20, 2012 – Ariosa Diagnostics, provider of the HarmonyTM Prenatal Test, today announced that WellPoint, which provides health benefits to more than 33 million people in the United States, has issued a medical policy update that deems cell-free fetal DNA-based prenatal screening for fetal aneuploidy (trisomies 13, 18, and 21) as medically necessary when certain clinical criteria are met. WellPoint supports cell-free DNA testing in women pregnant with a singleton fetus and considered at high risk for fetal aneuploidy (click here to read the full WellPoint policy.)

WellPoint also noted the importance of offering such testing by adequately trained healthcare professionals in order to provide women with appropriate pre- and post-test counseling as well as the importance for women with screen positive results to be offered confirmatory, invasive prenatal diagnostic testing. Regarding different testing methods, WellPoint highlighted one of the shortcomings of massively parallel sequencing: it is not selective in the chromosomal origin of the sequenced DNA fragments. An alternative that overcomes this limitation is the employment of DANSRTM and FORTETM, which are the principal assay and statistical components (respectively) of the Harmony Prenatal Test.

“We are encouraged by WellPoint’s recognition of the clinical utility of non-invasive prenatal testing using cell-free DNA,” said Dr. Ken Song, chief executive officer at Ariosa Diagnostics. “Our directed approach allows the Harmony Prenatal Test to be the most efficient cell-free DNA test as well as the most affordable non-invasive prenatal test at less than $1,000. We believe broad payer coverage of cell- free DNA testing will provide tremendous clinical benefit to patients and providers without increasing costs to the healthcare system.”

*The Harmony Prenatal Test is developed by Ariosa Diagnostics. Ariosa Diagnostics is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies.Non-invasive prenatal testing (NIPT) services based on cell-free DNA analyses are not diagnostic; results should be confirmed by diagnostic testing.Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.